– Key Opinion Leader and FORWARD trial investigator, Caroline Piatek, M.D., to join Rigel management to share experience and insight treating patients with wAIHA –
SOUTH SAN FRANCISCO, Calif., April 26, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will report its first quarter 2022 financial results after market close on Tuesday, May 3, 2022. Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.
The conference call will also feature a presentation by Key Opinion Leader and FORWARD trial investigator, Caroline Piatek, M.D., Associate Professor of Clinical Medicine, Jane Anne Nohl Division of Hematology at the Keck School of Medicine of the University of Southern California. Dr. Piatek will discuss the current treatment landscape, unmet medical need, patient journey, and how she may incorporate fostamatinib, if approved, into clinical practice in warm autoimmune hemolytic anemia (wAIHA).
Dr. Piatek's clinical focus is in non-malignant hematology. Her research interests include immune thrombocytopenia (ITP), wAIHA, cancer-associated thrombosis, and paroxysmal nocturnal hemoglobinuria.
Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.
About the FORWARD Phase 3 Study
Fostamatinib is currently being evaluated in a Phase 3 randomized, double-blind, placebo-controlled clinical study in 90 patients with wAIHA who have failed at least one prior treatment. The study will evaluate the efficacy of fostamatinib versus placebo in achieving a durable hemoglobin response, defined as a hemoglobin level ≥ 10 g/dL, with an increase from baseline and durability measure in hemoglobin level of ≥ 2 g/dL, with the response not being attributed to rescue therapy, on three consecutive available visits during the 24-week treatment period. Secondary endpoints include other measures of hemoglobin response, use of rescue medication, and safety. The pivotal trial is fully enrolled and topline data is expected in mid-2022.
The FDA has granted fostamatinib Orphan Drug and Fast Track designations for the treatment of patients with wAIHA.
Fostamatinib, commercially available in the U.S. under the brand name TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is the first and only FDA-approved SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment.
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product is also commercially available in Europe, the United Kingdom (TAVLESSE) and Canada (TAVALISSE) for the treatment of chronic immune thrombocytopenia in adult patients.
Fostamatinib is currently being studied in a Phase 3 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)1; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients with COVID-191; an NIH/NHLBI-sponsored Phase 3 clinical trial (ACTIV-4 Host Tissue Trial, NCT04924660) for the treatment of COVID-19 in hospitalized patients, and a Phase 2 clinical trial (NCT04581954) for the treatment of COVID-19 being conducted by Imperial College London.
Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIPK) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners BerGenBio ASA and Daiichi Sankyo.
Please see www.TAVALISSE.com for the full Prescribing Information.
1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.
Rigel Pharmaceuticals, Inc.
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SOURCE Rigel Pharmaceuticals, Inc.